File Copyright Online - File mutual Divorce in Delhi - Online Legal Advice - Lawyers in India

Patent In Pharmaceutical Industry

A patent acts as a limited barrier for new ideas and inventions. Patent is a legal right that is given to the inventor by the government for a specific period of time. No one can copy, use, sell or make the product without the permission of the inventor. Patents are essential for protecting the intellectual property and encouraging innovation.

Patents are important as they protect the new innovative ideas or the inventor. It gives the inventor the sole authority to control, manage and benefit from their innovation for a certain period of time. Patents protection guarantees the creation that inventors can gain profit from their innovative work and investment in their research and development. Patent also encourages competition and grow many kinds of industries by rewarding for their creation.

Patent plays a very important role in the pharmaceutical industries. It protects the new drugs, medicines and treatments in which a lot of time and money is invested by the company. If a pharmaceutical industry gets the patent for a drug then it means that they have the sole right for using or sale of that medicine for a certain period of time. This division helps companies recoup their research and development costs. It's also encouraging because companies know they can benefit from their discoveries. Without patents, companies cannot invest in the development of new drugs because they do not have the necessary protection to be effective. So patent plays a very crucial role in promoting innovation and enhancing healthcare by guaranteeing the development of the innovation.

Patents are exclusive rights that protect innovations in drug development in the pharmaceutical industry. They can be granted to inventors, pharmaceutical companies, or research organizations. Patents give the holder the right to prevent others from making, using, selling, or importing their patented inventions without permission for a set period of time.

Patents can cover the process of tangible items, for example drugs can be patented for formulations. during the life of patent, no other entity can sell any version of drugs, which can increase deflation or inflation, but companies may file secondary patents which are illegal in nature.

Patents also serves share knowledges, advantages and disadvantages of pharmaceutical sector as well as different entities such as, startups, research organisation, public safety, and many more. However, pharmaceutical patent requires a better knowledge and understanding related to pharmaceuticals sector as well as science and legal concepts, and require close amalgamation between law sector and pharmaceutical sector.

What Is Patent?

A patent has effective rights provided by the government (such as the US Patent and trademark office USPTO) of for invention which is new, added an inventive steps as well as capable for industrial application but in different way patents will not give you the personal rights to make your own products, they can only prevent others making, using, or selling of your product, or importing a product in different countries. Patent protection is limited to the country or any other countries that it was issued in and limited to a certain amount of time, mainly 20 years from the date of application filling of patients. Recently by the US food and drug administration government advices that pharmaceutical patent may be extended to compensate.

A patent discovery must be related to novel, non-obvious. An invention is defined as a new and inventive solution to technical problems, ideas, law of nature, human nature, behaviour, scientific principal. In order to be a patentable, an invention must have never been publicly disclosed or nor discussed in seminar, presentation, paper, even with your family and friends or colleagues. Once a discovery is granted a patent must fully disclose more details about the invention so that people can understand. On the other hand, the inventor couldn't disclose their invention by themselves but run the risk of it being unprotected and has a monopoly over it until the competition figure out.

Common Pharmaceutical Patent Extensions

There are many different types of pharmaceuticals patents in the world, depending on the drug they are protecting, the selectness of each patent can be extended by various method of lengths because drug invention, validation, and marketing can take more than 10 years. It emphasizes companies to study and develop new drugs by the extended time and effort during the development of drugs. This is equivalent important for drugs in understudied areas such as rare diseases , antibiotics, and population , because a large population of pharmaceuticals industries( up to 80% ) revenue comes from their patents they want to extend their patent as long as possible . once a patent expires, other companies can manufacture and sell the drug. patents for new chemical entities can be extend for five years under the FDA and European Medicines Agency (EMA) sponsors also receives up to 11 years of exclusivity for new drug, eight years of data exclusivity, two years of market exclusivity and one year of extension.

Patents for drugs with pediatric exclusivity (ones that include pediatric data) can enjoy an additional six months of exclusivity under the FDA and EMA.
Patents for certain new antibiotics can have an extra five years of exclusivity under the FDA.

Trips Agreement

The pharmaceutical patent is assume as true or real for a pharmaceutical substance which mean any new existence or matter involving one or more innovative or ingenious steps as per section 2 (t) of the Indian patent act. To turn over the new leaf of the trips agreement the pharmaceutical industry was highly unstable industry towards the patent protection. Their existed inconsistency or unevenness towards the health status and medical need of the people were largely unfulfilled. Then there exists only a process patent that provides protection to the pharmaceutical companies but for bow article 27 (1) of the trips extend the patent protection to the product as well as all the fields of technology.

The TRIPS Agreement came into effect on 1st January 1995. It is an agreement regarding intellectual property rights which is comprehensive and multilateral. The Agreement defines the standard to protect the domestic law provided by each member country. Under the TRIPS agreement, the main condition is that patent can be issued for inventive measures, no matter it is a product or the process, in all the categories of technology it should satisfy the three requirements that is novelty, inventive measures and industrial applicability.

Trips Flexibilities

A patent grants exclusive rights to the innovation which often allows the patent holder to enjoy a Monopoly position. Developing nations like India, where efforts are made to make medicine available to all the parts of India at a reasonable price, there is a high chance that pharmaceutical companies grab the chance to exploit the patent monopoly by charging high prices and preventing the local manufacturers from making common version of the drug. Therefore, some adaptable changes were made into the trip agreement so that the member countries could make a space for public interest by taking measures including to protect public health to reach their social goals.

Drugs developed under the pharmaceutical industry received patent protection under the trips agreement and their prices were increased as a result of the Monopoly. This creates a challenging condition for the developing Nations. For example, in Sub-Saharan Africa over 5 million people suffered from the disease but are still unable to afford the required drugs. This clearly indicates that the trip agreement doesn't want these developing countries to access essential medicine. The to address this issues that Doha declaration on trip and public health was adopted by members of the World Trade organisation in 2001.

The Doha declaration came into acceptance of the public health problem and they need trips to be a part of the solution to these health issues. The declaration seeks for the confirmation that the drips does not prevent member countries for taking measures to protect public health the Doha declaration came to the conclusion that trip should explain in such a way that it would support all members write to protect health and promote access to the medicine for all.

Compulsory Licensing

Under Article 31, on the basis of some protocols, the TRIPS agreement provides a way to promote public health by allowing the nation to issue a compulsory license. Without the patent holder's authorisation, a license is established by an administrative body to a third party to exploit an invention is called a compulsory license. It is referred to as a non- voluntary license connoting without any presence of consent by the patent holder.

For the promotion of research and development of new drugs by issuing compulsory license is the ultimate goal behind it. However, such licenses is a type of mode of payment for the enhancement of creating royalty in India. On the basis of that owner/ manufacturer has made enough efforts to produce a voluntary license from the patent holder on some specific terms within a specific period of time, compulsory license enables the license to obtain a generic copy of the drug to be made available in the local market at a price lesser than that of its competitor.

Compulsory Licensing Of Covid-19 Drugs And Vaccine In India
We have faced the shortage of medicine and vaccines. There has been demanding around in the market since the COVID-19 pandemic began in 2019. There was imbalance between supply and demand of market as the cases has rising rapidly. There were in discussion for past two years.

India had faced death rate around 7.3 per 1000 people. Most of the death was due to the most viral virus COVID -19. To meet the need of people which was covid drug and vaccines there was boon in the market to maintain the balance in their demand and supply. The government shared their intellectual property with other pharmaceutical companies to manufacture the urgent need of vaccine which leads to speeding up the production of drugs and vaccines.

The legality of compulsory licensing is concerned, there are many examples that initiate verification of compulsory licensing of pharmaceutical drugs in India. In the year 2012, the Indian patent office permit a compulsory licence to the Hyderabad - based drugmaker Natco to produce and sell a similar of buyer's Nexavar which is an excellent kidney cancer drug. In the year 2000, our country has observed that pharma based giant Cipla fighting against the government that is compulsory for the Anti-Aids drugs so clearly, the law grants it.

Currently, the private sector is bit more unwilling to make use of compulsory licences even when the government permit them because they are afraid of prolonged litigation being broadband or in future refused in the partnership by them even for contracted manufacture. The public health sector is the best example for undertaking the compulsory licences issued by the government has been destroyed by years of neglect. Nowadays most of the public health sector are closed or about to closed. It concluded that we have shot ourselves in the foot for not being able to make compulsory licences work to our advantage.

However, on 27th May, in a press statement NITI Ayog declared that India is not planning to issue any mandatory license regarding COVID-19 vaccines and the active cooperation of the companies that initially produced the vaccine is must.

In the Countries like South Africa and India, resolutions related to an international debate on whether patent rights should only be suspended for the vaccines but also for medicine and other equipment have been submitted to the WTO. The goal of the resolution is to permit many countries for manufacturing these products properly and thus minimising unnecessary global inequities.

Consequences Of Compulsory Licensing Of Pharmaceutical Drugs
Medicine's duplicates made under a compulsory licence may not meet the same quality standards. A compulsory license does not guarantee that the background knowledge of the company is sufficient to produce the drugs with the same potency as the original product.

New treatment approaches may be discouraged from developing as a result of a compulsory licensing. The fact that drug manufacturers have to imitate existing therapies in order to profit from existing patents to prevent them from focusing on developing new drugs.

Compulsory licensing discourages manufacturers from doing clinical trials in countries that don't honor patents. This is a loss for patients who miss a chance to receive treatment. It is also a loss for local economies which would otherwise get a boost from having clinical trials in a region.

India is a developing market for pharmaceuticals and it has made many efforts in research and development to produce its own pharma products.

The number of TRIPS (Trade Related Aspects of Intellectual Property Rights) restrictions have been cancelled to reciprocate WTO warnings that the epidemic poses an unprecedented threat to the global economy.

When it comes to compulsory licensing, we should ask Indian pharmaceutical companies whether they may use their manufacturing capacity to produce vaccines and high quality medicines. This will allow us to take advantage of the potential of obligatory licenses as a weapon. Indian private companies should participate in the mandatory licensing process for foreign-made vaccines as well. In this process, the government will ring-fence these private pharmaceutical companies, providing them with financial support to offset litigation costs and other potential legal repercussions.

Law Article in India

Ask A Lawyers

You May Like

Legal Question & Answers

Lawyers in India - Search By City

Copyright Filing
Online Copyright Registration


How To File For Mutual Divorce In Delhi


How To File For Mutual Divorce In Delhi Mutual Consent Divorce is the Simplest Way to Obtain a D...

Increased Age For Girls Marriage


It is hoped that the Prohibition of Child Marriage (Amendment) Bill, 2021, which intends to inc...

Facade of Social Media


One may very easily get absorbed in the lives of others as one scrolls through a Facebook news ...

Section 482 CrPc - Quashing Of FIR: Guid...


The Inherent power under Section 482 in The Code Of Criminal Procedure, 1973 (37th Chapter of t...

The Uniform Civil Code (UCC) in India: A...


The Uniform Civil Code (UCC) is a concept that proposes the unification of personal laws across...

Role Of Artificial Intelligence In Legal...


Artificial intelligence (AI) is revolutionizing various sectors of the economy, and the legal i...

Lawyers Registration
Lawyers Membership - Get Clients Online

File caveat In Supreme Court Instantly